Effectively prevent quality shortfalls with Quality Management System.

The Pharmaceutical, Life Science and Healthcare are few of the industries are rapidly adopting IT solutions to streamline, automate and expedite various processes involves in procurement, manufacturing and distribution or it’s better to say digitizing its self to make sure that companies are able to meet the standards of various quality and regulatory authorities and have their operations meet best practices.

Quality management system is one of today’s necessity to maintain high quality standards.
Pharmaceutical laboratories often handle potentially dangerous ingredients in their production and development of treatments. Be it the creation of a new cancer drug or the production of generics like Ibuprofen, laboratories and contract research organizations need to be able to maintain best practices in all of their operations.

Quality management system is one of the best solution to ensure this. Now a days Pharmaceutical players are finding out new cost effective ways to develop and market drugs. That’s why they are outsourcing various processes like R&D to laboratories and contractual manufacturing to other countries. According to Bloomberg BusinessWeek India, for instance, has been a major destination for these jobs, contributing to the $93 billion pipeline for generic drugs.

Quality management system plays a pivotal role for these laboratories, CRO’s and manufacturing facilities as they can digitally store data there, records are continually being maintained online, multiple departments are working on the same project can access this information, promoting greater collaboration and this means data can be more easily accessed and applied. However this makes it easier to properly input data, either internationally or domestic.

Here I would like share small story of well-known Indian player, manufacturing generic drugs, having factory in the northern Indian village of Toansa. During the sudden FDA visit the auditors found that windows were stuck open, machines were broken and there were numerous files scattered throughout the plant. As a result, the FDA banned the plant.

This may be one of the extreme example, but it highlights potential shortcomings to arise. Quality management system is not a be-all, end-all solution, but it can help companies make sure their digital systems are able to work continuously and migrate the potential of risk.